A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT00175877
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Results First Posted: March 8, 2013
• Last Update Posted: March 26, 2020
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Intervention: Biological: Certolizumab Pegol
• Enrollment: 857

Participant Flow

Recruitment Details	Enrollment of subjects started in June 2005. 121 centers in 22 countries enrolled subjects. Participant Flow refers to the Safety Set consisting of all enrolled subjects who received at least 1 dose of study medication. Of the 857 enrolled subjects, 846 subjects are included in the Safety Set. There was 1 enrolled subject who was never dosed.
Pre-assignment Details	The study consists of 2 populations: of subjects who failed to achieve predefined criteria in preceding study NCT00152386 who entered C87028 on Week 16 of preceding study and of those who completed Week 52 of preceding study. Due to findings of fraud at one site, data of the 10 subjects of the site were not analyzed with data from other sites.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Period Title: Overall Study
Started	846
Completed	497
Not Completed	349
Reason Not Completed
Adverse Event	136
Withdrawal by Subject	141
Lost to Follow-up	9
Lack of Efficacy	26
Protocol Violation	15
Other Reason	20
AE & Other	1
Withdrawal by subject & Other	1

Baseline Characteristics

Arm/Group Title		Certolizumab Pegol
Arm/Group Description		All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Baseline Participants		846
Baseline Analysis Population Description		Baseline Characteristics refer to the Safety Set (SS). SS consists of all enrolled subjects who received at least 1 dose of study medication.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	846 participants
	<=18 years	1 0.1%
	Between 18 and 65 years	736 87.0%
	>=65 years	109 12.9%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	846 participants
		51.5; (18 to 81)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	846 participants
	Female	701 82.9%
	Male	145 17.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	846 participants
Serbia		45
United States		56
Estonia		16
Slovakia		45
Finland		5
Ukraine		81
Lithuania		42
Russian Federation		102
Israel		24
Chile		11
France		2
Czech Republic		122
Hungary		57
Mexico		5
Canada		19
Argentina		122
Belgium		5
Croatia		3
Australia		12
Bulgaria		28
Latvia		26
New Zealand		18
Weight; Mean (Standard Deviation); Unit of measure: Kilogram (kg)
	Number Analyzed	846 participants
		73.69 (16.17)
Height; Mean (Standard Deviation); Unit of measure: Centimeter (cm)
	Number Analyzed	846 participants
		164.30 (8.88)

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
Description	An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
Time Frame	From first dose of CZP to the end of the open-label study (approximately 7 years)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	846
Measure Type: Number; Unit of Measure: percentage of participants
	94.9

2. Primary Outcome

Title	Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
Description	A SAE is any untoward medical occurrence that at any dose: Results in death; Is life-threatening; Requires in patient hospitalisation or prolongation of existing hospitalisation; Results in persistent or significant disability/incapacity, or; Is a congenital anomaly or birth defect; Is as infection that requires treatment parenteral antibiotics; Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above First dose of CZP was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
Time Frame	From first dose of CZP to the end of the open-label study (approximately 7 years)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	846
Measure Type: Number; Unit of Measure: percentage of participants
	41.6

3. Primary Outcome

Title	Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study
Description	An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
Time Frame	From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	846
Measure Type: Number; Unit of Measure: percentage of participants
	16.2

4. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48
Description	The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 48 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	733
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	87.0; (84.4 to 89.4)

5. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96
Description	The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 96 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	668
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	88.0; (85.3 to 90.4)

6. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144
Description	The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 144 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	602
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	87.9; (85.0 to 90.4)

7. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192
Description	The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 192 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	537
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	89.4; (86.5 to 91.9)

8. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240
Description	The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 240 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	183
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	82.5; (76.2 to 87.7)

9. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal
Description	The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	841
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	81.3; (78.5 to 83.9)

10. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48
Description	The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 48 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	733
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	63.0; (59.4 to 66.5)

11. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96
Description	The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 96 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	668
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	66.0; (62.3 to 69.6)

12. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144
Description	The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 144 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	602
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	65.4; (61.5 to 69.2)

13. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192
Description	The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 192 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	537
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	64.8; (60.6 to 68.8)

14. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240
Description	The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 240 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	183
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	58.5; (51.0 to 65.7)

15. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal
Description	The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	841
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	57.6; (54.1 to 60.9)

16. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48
Description	The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 48 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	733
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	37.7; (34.1 to 41.3)

17. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96
Description	The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 96 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	668
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	40.7; (37.0 to 44.6)

18. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144
Description	The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 144 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	602
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	41.2; (37.2 to 45.2)

19. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192
Description	The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 192 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	537
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	42.8; (38.6 to 47.1)

20. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240
Description	The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Week 240 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	183
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	34.4; (27.6 to 41.8)

21. Secondary Outcome

Title	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal
Description	The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	841
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	38.2; (34.9 to 41.5)

22. Secondary Outcome

Title	Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)
Description	The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame	From Baseline of the preceding double-blind study to Week 96 of the open-label study

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 661 are included in this analysis. Data not available for 185 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	661
Mean (Standard Deviation); Unit of Measure: units on a scale
	0.95 (4.79)

23. Secondary Outcome

Title	Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score
Description	The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.
Time Frame	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 824 are included in this analysis. Data not available for 22 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	824
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.674 (0.640)

24. Secondary Outcome

Title	Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness
Description	Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 838 are included in this analysis. Data not available for 8 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	838
Mean (Standard Deviation); Unit of Measure: hours
	-2.147 (3.846)

25. Secondary Outcome

Title	Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])
Description	DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.
Time Frame	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	834
Mean (Standard Deviation); Unit of Measure: units on a scale
	-3.222 (1.511)

26. Secondary Outcome

Title	Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit
Description	Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.
Time Frame	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	834
Measure Type: Number; Unit of Measure: percentage of participants
	42.4

27. Secondary Outcome

Title	Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score
Description	The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).
Time Frame	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	777
Mean (Standard Deviation); Unit of Measure: units on a scale
	8.813 (9.092)

28. Secondary Outcome

Title	Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score
Description	The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).
Time Frame	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Outcome Measure Data

Analysis Population Description

Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Number of Participants Analyzed	777
Mean (Standard Deviation); Unit of Measure: units on a scale
	4.612 (12.592)

Adverse Events

Time Frame	Adverse Events (AEs) were collected up to approximately 7 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study.
Adverse Event Reporting Description	AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Arm/Group Title	Certolizumab Pegol
Arm/Group Description	All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
All-Cause Mortality
	Certolizumab Pegol
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Certolizumab Pegol
	Affected / at Risk (%)	# Events
Total	352/846 (41.61%)
Blood and lymphatic system disorders
Iron deficiency anaemia * 1	1/846 (0.12%)	1
Anaemia * 1	2/846 (0.24%)	2
Neutrophilia * 1	1/846 (0.12%)	1
Lymphadenitis * 1	1/846 (0.12%)	1
Lymphadenopathy * 1	1/846 (0.12%)	1
Lymphadenopathy mediastinal * 1	1/846 (0.12%)	2
Pancytopenia * 1	1/846 (0.12%)	1
Cardiac disorders
Aortic valve disease * 1	1/846 (0.12%)	1
Atrioventricular block complete * 1	1/846 (0.12%)	1
Ischaemic cardiomyopathy * 1	1/846 (0.12%)	1
Coronary artery disease * 1	1/846 (0.12%)	1
Cardiac failure * 1	4/846 (0.47%)	4
Acute myocardial infarction * 1	1/846 (0.12%)	1
Angina pectoris * 1	4/846 (0.47%)	4
Angina unstable * 1	2/846 (0.24%)	2
Myocardial infarction * 1	5/846 (0.59%)	7
Myocardial ischaemia * 1	3/846 (0.35%)	3
Mitral valve incompetence * 1	1/846 (0.12%)	1
Myocarditis * 1	1/846 (0.12%)	1
Arrhythmia * 1	1/846 (0.12%)	1
Atrioventricular extrasystoles * 1	1/846 (0.12%)	1
Extrasystoles * 1	1/846 (0.12%)	1
Arrhythmia supraventricular * 1	1/846 (0.12%)	1
Atrial fibrillation * 1	6/846 (0.71%)	7
Supraventricular tachycardia * 1	1/846 (0.12%)	1
Cardiac arrest * 1	1/846 (0.12%)	1
Congenital, familial and genetic disorders
Arnold-Chiari malformation * 1	1/846 (0.12%)	1
Ear and labyrinth disorders
Vertigo * 1	1/846 (0.12%)	1
Vertigo positional * 1	1/846 (0.12%)	1
Eye disorders
Cataract * 1	4/846 (0.47%)	5
Macular hole * 1	1/846 (0.12%)	2
Retinal detachment * 1	1/846 (0.12%)	1
Gastrointestinal disorders
Abdominal hernia * 1	1/846 (0.12%)	1
Pancreatitis * 1	1/846 (0.12%)	1
Pancreatitis chronic * 1	1/846 (0.12%)	1
Tooth impacted * 1	1/846 (0.12%)	1
Hiatus hernia * 1	1/846 (0.12%)	1
Duodenal ulcer * 1	1/846 (0.12%)	1
Femoral hernia * 1	1/846 (0.12%)	1
Gastric ulcer * 1	1/846 (0.12%)	1
Gastritis * 1	1/846 (0.12%)	1
Abdominal pain * 1	4/846 (0.47%)	4
Gastrointestinal motility disorder * 1	1/846 (0.12%)	1
Ileus * 1	1/846 (0.12%)	2
Inguinal hernia * 1	4/846 (0.47%)	4
Nausea * 1	1/846 (0.12%)	1
Vomiting * 1	4/846 (0.47%)	4
Megacolon * 1	1/846 (0.12%)	1
Gastrointestinal haemorrhage * 1	1/846 (0.12%)	1
Melaena * 1	1/846 (0.12%)	1
Lip ulceration * 1	1/846 (0.12%)	1
General disorders
Asthenia * 1	1/846 (0.12%)	1
Sudden death * 1	2/846 (0.24%)	2
Pyrexia * 1	5/846 (0.59%)	5
Chest pain * 1	2/846 (0.24%)	2
Non-cardiac chest pain * 1	1/846 (0.12%)	1
Hepatobiliary disorders
Cholecystitis * 1	3/846 (0.35%)	3
Cholecystitis acute * 1	1/846 (0.12%)	1
Cholelithiasis * 1	10/846 (1.18%)	10
Hepatic cyst * 1	1/846 (0.12%)	1
Hepatitis alcoholic * 1	1/846 (0.12%)	1
Immune system disorders
Sarcoidosis * 1	3/846 (0.35%)	3
Allergy to arthropod bite * 1	1/846 (0.12%)	1
Infections and infestations
Anorectal infection * 1	1/846 (0.12%)	1
Appendicitis * 1	3/846 (0.35%)	3
Diverticulitis * 1	1/846 (0.12%)	1
Gastroenteritis * 1	3/846 (0.35%)	3
Peritoneal infection * 1	1/846 (0.12%)	1
Arthritis bacterial * 1	6/846 (0.71%)	6
Asymptomatic bacteriuria * 1	2/846 (0.24%)	2
Cellulitis * 1	11/846 (1.30%)	12
Folliculitis * 1	1/846 (0.12%)	1
Arthritis infective * 1	2/846 (0.24%)	2
Bursitis infective * 1	3/846 (0.35%)	3
Sialoadenitis * 1	1/846 (0.12%)	1
Tooth abscess * 1	1/846 (0.12%)	1
Ear infection * 1	2/846 (0.24%)	2
Otitis media acute * 1	1/846 (0.12%)	1
Infectious mononucleosis * 1	1/846 (0.12%)	1
Escherichia infection * 1	1/846 (0.12%)	1
Dacryocystitis infective * 1	1/846 (0.12%)	1
Salpingitis * 1	1/846 (0.12%)	1
Geotrichum infection * 1	1/846 (0.12%)	1
Cholecystitis infective * 1	1/846 (0.12%)	1
Herpes zoster * 1	5/846 (0.59%)	5
Herpes zoster disseminated * 1	1/846 (0.12%)	1
Histoplasmosis * 1	1/846 (0.12%)	1
Abscess soft tissue * 1	1/846 (0.12%)	1
Device related infection * 1	3/846 (0.35%)	3
Groin abscess * 1	1/846 (0.12%)	1
Localised infection * 1	1/846 (0.12%)	1
Postoperative wound infection * 1	3/846 (0.35%)	3
Wound infection * 1	1/846 (0.12%)	1
Bronchitis * 1	4/846 (0.47%)	4
Bronchitis acute * 1	5/846 (0.59%)	6
Bronchitis chronic * 1	1/846 (0.12%)	2
Bronchopneumonia * 1	2/846 (0.24%)	2
Lobar pneumonia * 1	2/846 (0.24%)	2
Lower respiratory tract infection * 1	1/846 (0.12%)	1
Obstructive chronic bronchitis with acute exacerbation * 1	1/846 (0.12%)	1
Pneumonia * 1	29/846 (3.43%)	31
Pyothorax * 1	2/846 (0.24%)	2
Nocardiosis * 1	1/846 (0.12%)	1
Condyloma acuminatum * 1	1/846 (0.12%)	1
Gastroenteritis salmonella * 1	2/846 (0.24%)	2
Sepsis * 1	4/846 (0.47%)	4
Urosepsis * 1	2/846 (0.24%)	2
Burn infection * 1	1/846 (0.12%)	1
Furuncle * 1	2/846 (0.24%)	2
Pyoderma * 1	1/846 (0.12%)	1
Soft tissue infection * 1	1/846 (0.12%)	1
Subcutaneous abscess * 1	5/846 (0.59%)	5
Pneumonia staphylococcal * 1	1/846 (0.12%)	1
Staphylococcal bacteraemia * 1	1/846 (0.12%)	1
Erysipelas * 1	6/846 (0.71%)	6
Meningitis streptococcal * 1	1/846 (0.12%)	1
Streptococcal bacteraemia * 1	1/846 (0.12%)	1
Disseminated tuberculosis * 1	4/846 (0.47%)	4
Pulmonary tuberculosis * 1	9/846 (1.06%)	9
Tuberculosis * 1	3/846 (0.35%)	3
Tuberculous pleurisy * 1	2/846 (0.24%)	2
Acute sinusitis * 1	2/846 (0.24%)	2
Acute tonsillitis * 1	1/846 (0.12%)	1
Chronic sinusitis * 1	1/846 (0.12%)	2
Chronic tonsillitis * 1	1/846 (0.12%)	1
Laryngitis * 1	1/846 (0.12%)	1
Laryngopharyngitis * 1	1/846 (0.12%)	1
Nasal vestibulitis * 1	1/846 (0.12%)	1
Pharyngitis * 1	3/846 (0.35%)	3
Rhinitis * 1	1/846 (0.12%)	1
Sinusitis * 1	3/846 (0.35%)	3
Tonsillitis * 1	4/846 (0.47%)	5
Pyelonephritis * 1	1/846 (0.12%)	1
Pyelonephritis acute * 1	4/846 (0.47%)	5
Urinary tract infection * 1	5/846 (0.59%)	5
Viral infection * 1	1/846 (0.12%)	1
Yersinia bacteraemia * 1	1/846 (0.12%)	1
Injury, poisoning and procedural complications
Concussion * 1	4/846 (0.47%)	5
Traumatic brain injury * 1	1/846 (0.12%)	1
Haemothorax * 1	1/846 (0.12%)	1
Dislocation of joint prosthesis * 1	1/846 (0.12%)	1
Complication of device removal * 1	1/846 (0.12%)	1
Joint dislocation * 1	1/846 (0.12%)	1
Multiple fractures * 1	1/846 (0.12%)	1
Anastomotic ulcer * 1	1/846 (0.12%)	1
Joint injury * 1	2/846 (0.24%)	2
Limb traumatic amputation * 1	1/846 (0.12%)	1
Meniscus lesion * 1	1/846 (0.12%)	1
Femoral neck fracture * 1	3/846 (0.35%)	3
Femur fracture * 1	2/846 (0.24%)	2
Foot fracture * 1	1/846 (0.12%)	1
Hip fracture * 1	3/846 (0.35%)	4
Lower limb fracture * 1	6/846 (0.71%)	6
Tibia fracture * 1	3/846 (0.35%)	3
Tendon rupture * 1	1/846 (0.12%)	1
Excoriation * 1	1/846 (0.12%)	1
Polytraumatism * 1	1/846 (0.12%)	1
Wound secretion * 1	1/846 (0.12%)	1
Post procedural haemorrhage * 1	1/846 (0.12%)	1
Seroma * 1	1/846 (0.12%)	2
Intentional overdose * 1	1/846 (0.12%)	1
Overdose * 1	2/846 (0.24%)	2
Acetabulum fracture * 1	1/846 (0.12%)	1
Pelvic fracture * 1	2/846 (0.24%)	2
Drug toxicity * 1	1/846 (0.12%)	1
Neck injury * 1	1/846 (0.12%)	1
Vertebral injury * 1	1/846 (0.12%)	1
Contusion * 1	2/846 (0.24%)	2
Skin laceration * 1	2/846 (0.24%)	2
Skull fracture * 1	1/846 (0.12%)	1
Dislocation of vertebra * 1	2/846 (0.24%)	2
Thoracic vertebral fracture * 1	1/846 (0.12%)	1
Rib fracture * 1	1/846 (0.12%)	1
Forearm fracture * 1	3/846 (0.35%)	3
Hand fracture * 1	1/846 (0.12%)	1
Humerus fracture * 1	2/846 (0.24%)	2
Radius fracture * 1	1/846 (0.12%)	1
Upper limb fracture * 1	5/846 (0.59%)	5
Wrist fracture * 1	2/846 (0.24%)	2
Investigations
Blood creatinine increased * 1	1/846 (0.12%)	1
Blood urea increased * 1	1/846 (0.12%)	1
Smear cervix abnormal * 1	1/846 (0.12%)	1
Chest X-ray abnormal * 1	1/846 (0.12%)	2
Blood creatine phosphokinase increased * 1	1/846 (0.12%)	1
Neutrophil count decreased * 1	1/846 (0.12%)	1
Metabolism and nutrition disorders
Diabetes mellitus * 1	2/846 (0.24%)	2
Hypercholesterolaemia * 1	1/846 (0.12%)	1
Hypoglycaemia * 1	2/846 (0.24%)	2
Ketoacidosis * 1	1/846 (0.12%)	1
Musculoskeletal and connective tissue disorders
Arthritis * 1	4/846 (0.47%)	5
Osteonecrosis * 1	7/846 (0.83%)	8
Finger deformity * 1	1/846 (0.12%)	1
Foot deformity * 1	1/846 (0.12%)	1
Knee deformity * 1	1/846 (0.12%)	1
Lower limb deformity * 1	1/846 (0.12%)	3
Toe deformity * 1	3/846 (0.35%)	3
Upper limb deformity * 1	1/846 (0.12%)	1
Wrist deformity * 1	1/846 (0.12%)	2
Intervertebral disc protusion * 1	2/846 (0.24%)	2
Joint destruction * 1	2/846 (0.24%)	2
Arthralgia * 1	4/846 (0.47%)	4
Back pain * 1	3/846 (0.35%)	3
Flank pain * 1	1/846 (0.12%)	1
Pain in extremity * 1	1/846 (0.12%)	1
Osteoarthritis * 1	8/846 (0.95%)	9
Osteoporotic fracture * 1	1/846 (0.12%)	1
Rheumatoid arthritis * 1	34/846 (4.02%)	38
Rheumatoid nodule * 1	1/846 (0.12%)	1
Scoliosis * 1	1/846 (0.12%)	1
Spondylitis * 1	1/846 (0.12%)	1
Synovial cyst * 1	1/846 (0.12%)	1
Synovitis * 1	1/846 (0.12%)	1
Shoulder deformity * 1	1/846 (0.12%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer * 1	3/846 (0.35%)	3
Colon cancer * 1	2/846 (0.24%)	2
Thyroid neoplasm * 1	1/846 (0.12%)	1
Endometrial cancer * 1	1/846 (0.12%)	1
Gastric cancer stage IV * 1	1/846 (0.12%)	1
Malignant peritoneal neoplasm * 1	1/846 (0.12%)	1
Lip and/ or oral cavity cancer * 1	1/846 (0.12%)	1
Castleman's disease * 1	1/846 (0.12%)	1
Metastases to central nervous system * 1	1/846 (0.12%)	1
Metastases to liver * 1	1/846 (0.12%)	1
Metastases to lung * 1	1/846 (0.12%)	1
Myeloproliferative disorder * 1	1/846 (0.12%)	1
Neoplasm malignant * 1	2/846 (0.24%)	2
Squamous cell carcinoma * 1	1/846 (0.12%)	1
Meningioma * 1	1/846 (0.12%)	1
Ovarian adenoma * 1	1/846 (0.12%)	1
Ovarian germ cell teratoma benign * 1	1/846 (0.12%)	1
Renal cell carcinoma stage II * 1	1/846 (0.12%)	1
Small cell lung cancer stage unspecified * 1	1/846 (0.12%)	1
Malignant melanoma * 1	2/846 (0.24%)	2
Basal cell carcinoma * 1	3/846 (0.35%)	4
Squamous cell carcinoma of skin * 1	1/846 (0.12%)	1
Benign urinary tract neoplasm * 1	1/846 (0.12%)	1
Uterine leiomyoma * 1	3/846 (0.35%)	3
Uterine cancer * 1	1/846 (0.12%)	1
Vaginal cancer stage 0 * 1	1/846 (0.12%)	1
Nervous system disorders
Cerebral haemorrhage * 1	1/846 (0.12%)	1
Cerebrovascular accident * 1	4/846 (0.47%)	5
Ischaemic cerebral infarction * 1	1/846 (0.12%)	1
Cerebrovascular disorder * 1	1/846 (0.12%)	1
Vertebrobasilar insufficiency * 1	1/846 (0.12%)	1
Cervicobrachial syndrome * 1	1/846 (0.12%)	1
Diabetic neuropathy * 1	1/846 (0.12%)	1
Syncope * 1	3/846 (0.35%)	3
Syncope vasovagal * 1	1/846 (0.12%)	1
Grand mal convulsion * 1	1/846 (0.12%)	1
Headache * 1	2/846 (0.24%)	2
Dizziness * 1	1/846 (0.12%)	1
Hemiparesis * 1	1/846 (0.12%)	1
Radiculopathy * 1	1/846 (0.12%)	1
Transient ischaemic attack * 1	2/846 (0.24%)	2
Pregnancy, puerperium and perinatal conditions
Pregnancy * 1	3/846 (0.35%)	3
Pregnancy on oral contraceptive * 1	1/846 (0.12%)	1
Psychiatric disorders
Bipolar disorder * 1	1/846 (0.12%)	1
Confusional state * 1	1/846 (0.12%)	1
Depression * 1	3/846 (0.35%)	4
Conversion disorder * 1	1/846 (0.12%)	1
Suicide attempt * 1	1/846 (0.12%)	1
Renal and urinary disorders
Stress incontinence * 1	1/846 (0.12%)	1
Bladder prolapse * 1	1/846 (0.12%)	1
Glomerulonephritis membranoproliferative * 1	1/846 (0.12%)	1
Renal failure * 1	1/846 (0.12%)	1
Renal cyst * 1	1/846 (0.12%)	1
Haematuria * 1	1/846 (0.12%)	1
Calculus ureteric * 1	1/846 (0.12%)	1
Renal colic * 1	4/846 (0.47%)	4
Reproductive system and breast disorders
Cervical dysplasia * 1	1/846 (0.12%)	1
Cervical polyp * 1	2/846 (0.24%)	2
Metrorrhagia * 1	4/846 (0.47%)	4
Ovarian cyst * 1	2/846 (0.24%)	2
Ovarian haemorrhage * 1	1/846 (0.12%)	1
Uterine prolapse * 1	2/846 (0.24%)	2
Vaginal prolapse * 1	1/846 (0.12%)	1
Benign prostatic hyperplasia * 1	1/846 (0.12%)	1
Pelvic pain * 1	1/846 (0.12%)	1
Endometrial hyperplasia * 1	2/846 (0.24%)	2
Uterine haemorrhage * 1	1/846 (0.12%)	1
Uterine polyp * 1	2/846 (0.24%)	2
Bartholin's cyst * 1	1/846 (0.12%)	1
Vaginal haemorrhage * 1	1/846 (0.12%)	1
Respiratory, thoracic and mediastinal disorders
Asthma * 1	1/846 (0.12%)	1
Chronic obstructive pulmonary disease * 1	4/846 (0.47%)	5
Alveolitis fibrosing * 1	1/846 (0.12%)	1
Nasal polyps * 1	1/846 (0.12%)	1
Emphysema * 1	1/846 (0.12%)	1
Interstitial lung disease * 1	1/846 (0.12%)	1
Lung infiltration * 1	2/846 (0.24%)	2
Pleurisy * 1	2/846 (0.24%)	2
Hydrothorax * 1	1/846 (0.12%)	1
Pleural effusion * 1	5/846 (0.59%)	6
Pneumothorax * 1	1/846 (0.12%)	1
Acute pulmonary oedema * 1	1/846 (0.12%)	1
Pulmonary embolism * 1	5/846 (0.59%)	5
Respiratory failure * 1	2/846 (0.24%)	2
Skin and subcutaneous tissue disorders
Dermatitis allergic * 1	1/846 (0.12%)	1
Pityriasis rosea * 1	1/846 (0.12%)	1
Pruritus generalised * 1	1/846 (0.12%)	1
Purpura * 1	1/846 (0.12%)	1
Rash * 1	1/846 (0.12%)	1
Skin ulcer * 1	1/846 (0.12%)	1
Urticaria * 1	1/846 (0.12%)	1
Surgical and medical procedures
Joint arthroplasty * 1	3/846 (0.35%)	3
Knee arthroplasty * 1	3/846 (0.35%)	3
Synovectomy * 1	1/846 (0.12%)	1
Brain operation * 1	1/846 (0.12%)	1
Therapy regimen changed * 1	1/846 (0.12%)	1
Hysterectomy * 1	1/846 (0.12%)	1
Vascular disorders
Haematoma * 1	1/846 (0.12%)	1
Post thrombotic syndrome * 1	1/846 (0.12%)	1
Thrombosis * 1	1/846 (0.12%)	1
Venous thrombosis * 1	3/846 (0.35%)	3
Arteriosclerosis * 1	1/846 (0.12%)	1
Deep vein thrombosis * 1	6/846 (0.71%)	6
Trombophlebitis * 1	1/846 (0.12%)	1
Venous thrombosis limb * 1	3/846 (0.35%)	4
Essential hypertension * 1	1/846 (0.12%)	1
Hypertension * 1	2/846 (0.24%)	2
Orthostatic hypotension * 1	1/846 (0.12%)	1
Rheumatoid vasculitis * 1	2/846 (0.24%)	2
Vasculitis * 1	1/846 (0.12%)	1
Vena cava thrombosis * 1	1/846 (0.12%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (9.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Certolizumab Pegol
	Affected / at Risk (%)	# Events
Total	682/846 (80.61%)
Blood and lymphatic system disorders
Anaemia * 1	57/846 (6.74%)	77
Eye disorders
Conjunctivitis * 1	55/846 (6.50%)	77
Gastrointestinal disorders
Diarrhoea * 1	66/846 (7.80%)	90
Nausea * 1	53/846 (6.26%)	84
Dyspepsia * 1	57/846 (6.74%)	76
Gastritis * 1	48/846 (5.67%)	59
General disorders
Pyrexia * 1	59/846 (6.97%)	86
Infections and infestations
Urinary tract infection * 1	150/846 (17.73%)	280
Nasopharyngitis * 1	158/846 (18.68%)	270
Upper respiratory tract infection * 1	138/846 (16.31%)	267
Bronchitis acute * 1	99/846 (11.70%)	134
Pharyngitis * 1	86/846 (10.17%)	132
Herpes simplex * 1	71/846 (8.39%)	131
Influenza * 1	87/846 (10.28%)	115
Sinusitis * 1	72/846 (8.51%)	110
Bronchitis * 1	66/846 (7.80%)	89
Rhinitis * 1	56/846 (6.62%)	75
Respiratory tract infection * 1	45/846 (5.32%)	74
Investigations
Hepatic enzyme increased * 1	45/846 (5.32%)	73
Alanine aminotransferase increased * 1	52/846 (6.15%)	72
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis * 1	133/846 (15.72%)	225
Back pain * 1	103/846 (12.17%)	150
Arthralgia * 1	71/846 (8.39%)	119
Nervous system disorders
Headache * 1	92/846 (10.87%)	140
Psychiatric disorders
Depression * 1	43/846 (5.08%)	54
Respiratory, thoracic and mediastinal disorders
Cough * 1	58/846 (6.86%)	77
Skin and subcutaneous tissue disorders
Rash * 1	63/846 (7.45%)	84
Vascular disorders
Hypertension * 1	159/846 (18.79%)	242
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (9.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB
• Phone: +1 877 822 9493 (UCB)

Publications of Results:

Keystone EC, Combe B, Smolen J, Strand V, Goel N, van Vollenhoven R, Mease P, Landewe R, Fleischmann R, Luijtens K, van der Heijde D. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford). 2012 Sep;51(9):1628-38. doi: 10.1093/rheumatology/kes082. Epub 2012 May 16.

van der Heijde D, Keystone EC, Curtis JR, Landewe RB, Schiff MH, Khanna D, Kvien TK, Ionescu L, Gervitz LM, Davies OR, Luijtens K, Furst DE. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disease activity at 1 year in rheumatoid arthritis patients treated with certolizumab pegol: a post-hoc analysis of the RAPID 1 trial. J Rheumatol. 2012 Jul;39(7):1326-33. doi: 10.3899/jrheum.111171. Epub 2012 May 15.

Curtis JR, Chen L, Luijtens K, Navarro-Millan I, Goel N, Gervitz L, Weinblatt M. Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level data. Arthritis Rheum. 2011 Aug;63(8):2203-8. doi: 10.1002/art.30387.

Other Publications:

Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y.

Smolen J, Landewe RB, Mease P, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff M, Burmester GR, Strand V, Vencovsky J, van der Heijde D. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009 Jun;68(6):797-804. doi: 10.1136/ard.2008.101659. Epub 2008 Nov 17.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00175877
• Other Study ID Numbers: C87028; 2005-001350-24 ( EudraCT Number )
• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Results First Submitted: February 4, 2013
• Results First Posted: March 8, 2013
• Last Update Posted: March 26, 2020